An opioid treatment program cannot dispense methadone until four separate bodies have approved it. SAMHSA calls the federal part a triplicate process, because certification depends on the state and DEA, and the state and DEA often wait on each other. The order matters more than any single form.
The four approvals
- Approval 1
The state
Your state license and the State Opioid Treatment Authority’s approval. SAMHSA lists a contact for every state, DC, Puerto Rico and the Virgin Islands, though some entries name no agency. A few states add a gate first: Tennessee requires a certificate of need, and Mississippi will not certify a new program where existing services already meet the need. Louisiana repealed its need review in 2026.
- Approval 2
SAMHSA certification
Form SMA-162, signed by the program sponsor and submitted through the OTP Extranet from the sponsor’s own account (42 CFR 8.11). SAMHSA grants provisional certification for up to one year once you have applied for accreditation, and says it will not grant it without state and DEA approvals.
- Approval 3
OTP accreditation
A separate accreditation as an OTP from a SAMHSA-approved body such as CARF, Social Current or The Joint Commission. Existing behavioral health accreditation does not carry over to a new OTP.
- Approval 4
DEA registration
DEA Form 363, signed by an officer, partner or the applicant, with DEA’s fee ($296). A narcotic treatment program registration lasts one year and is renewed on Form 363a; the program must be registered before it administers or dispenses (21 CFR 1301.13; 42 CFR 8.11(e)(6)).
What the 2024 rule changed
SAMHSA’s 2024 rule (89 FR 7528, effective April 2, 2024, compliance by October 2, 2024) dropped the one-year opioid use disorder history for admission, let any practitioner the state licenses to prescribe or dispense serve as a practitioner, and widened methadone take-home doses at the practitioner’s discretion. It allows audio-video intake for methadone and audio-only for buprenorphine, and interim treatment for up to 180 days with state approval. A correcting rule followed on February 23, 2026 (91 FR 8382).
After approval
SAMHSA certification lasts up to three years and is renewed in its final year, with accreditation kept current; a lapsed program starts over as new. Sponsor or medical director changes go to SAMHSA within three weeks. A new medication unit needs SAMHSA approval: a fixed unit also needs its own DEA registration, and a mobile unit runs under the program’s registration with the local DEA office’s written approval, only in its own state.
Want the packet prepared?
The Opioid Treatment Program Approval Package is $6,995, plus the state license package. We prepare each approval in order; your sponsor and officers sign and submit from their own accounts, and you pay every state, DEA and accreditation fee directly. Every fee is flat. See every price, or check your state.
Questions
- Does our current accreditation cover a new OTP?
- No. SAMHSA requires a separate application for accreditation as an OTP, even for an organization already accredited for other behavioral health services.
- How long does SAMHSA take?
- SAMHSA says it requests 45 days to decide, and it will not grant provisional certification until the state and DEA have approved. Your state and DEA set their own pace, so we never promise a date.
- Who signs the SMA-162 and the DEA form?
- The program sponsor signs and submits the SMA-162 from the sponsor’s own OTP Extranet account, and an officer, partner or the applicant signs the DEA form. We prepare the information for both, and we never accept a DEA power of attorney.
- Can an OTP enroll in Medicare?
- Yes, on the CMS-855A or 855B (not both), once it holds full SAMHSA certification; provisional certification does not qualify (42 CFR 424.67). The program sponsor and medical director are reported as managing employees, and newly enrolling OTPs without continuous certification since October 23, 2018 are screened at the high level (42 CFR 424.67, 424.518).
Sources: 42 CFR Part 8, 89 FR 7528, 21 CFR 1301, 42 CFR 424. Not affiliated with SAMHSA, DEA, CMS, any state opioid treatment authority or any accrediting body.